Recall Z-2538-2014— Smiths Medical ASD, Inc.

Name: FDA recall Z-2538-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-07

Class I · Terminated

Class I FDA medical device recall by Smiths Medical ASD, Inc., initiated 2014-07-07, terminated 2021-05-26. It names one FDA 510(k) clearance: K790312. Product: H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit. Reason: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter..

Recalling firm: Smiths Medical ASD, Inc.
Classification: Class I
Status: Terminated
Initiated: 2014-07-07
Terminated: 2021-05-26
Firm location: Keene, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K790312 — ENDOTRACHEAL TUBE W/HOLDER & CONNECTORRespiratory Support Products, Inc.·cleared 1979-02-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit

Reason for recall

The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

Data sourced from openFDA. This site is unofficial and independent of the FDA.